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Phase III Clinical Studies of Aclidinium Bromide Show Statistical Significance vs. Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Date:9/2/2008

ere 1.406 and 1.199L for ACCLAIM/COPD I and ACCLAIM/COPD II, respectively. Patients were randomized to receive aclidinium bromide (200 micrograms once daily) or placebo over a one-year treatment period.

The primary endpoints for ACCLAIM/COPD I and II were bronchodilation at the end of the dosing interval, assessed as trough FEV1 (measured at 23-24h post-dose). For both trials, the primary endpoint was measured at week 12 and week 28 to fulfill FDA and European requirements, respectively.

Aclidinium bromide and placebo were administered to patients using the Genuair(R)(1) device, a multi-dose dry powder inhaler which operates by a 'one press and inhale' technique.

Overall, safety and tolerability were comparable between aclidinium and placebo in terms of percentage of patients with Serious Adverse Events (aclidinium: 9.1%, placebo 10.7%), Fatal Adverse Events (aclidinium: 1.1%, placebo: 1.7%), or with Adverse Events leading to treatment discontinuation (aclidinium: 4.0%, placebo: 5.7%). The most frequently reported adverse events across both studies were nasopharyngitis (aclidinium: 14.5%, placebo: 12.9%) and headache (aclidinium: 12.7%, placebo: 12.6%). Potential anticholinergic adverse events were observed in a similarly low percentage of patients, (e.g. dry mouth - aclidinium: 0.7%, placebo: 1.2%).

"Almirall remains committed to continue the efforts to provide treatment options for COPD patients with aclidinium bromide", commented Jorge Gallardo, Chairman and Chief Executive Officer of Almirall.

About COPD

The World Health Organisation (WHO) has described COPD as a global epidemic; an estimated 210 million people have COPD worldwide and more than 3 million people died of the condition in 2005, which is equal to 5% of all deaths globally that year. Total deaths from COPD are projected to increase by more than 30% in the next 10 years without interventions to cut risks, particularly exposure to tobacco smoke.

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SOURCE Forest Laboratories, Inc.
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